N/A N=73 Randomized Quadruple-blind Treatment

A Trial of Aprepitant For Prevention of Post-Endoscopic Retrograde Cholangiopancreatography (ERCP) Pancreatitis

Pancreatitis

Bottom Line

View on ClinicalTrials.gov: NCT00736073 ↗

Enrolled (actual)

Serious AEs

19.2%

Results posted

Apr 2013

Primary outcome: Primary: Number of Post-ERCP Pancreatitis Cases in Participants Who Are Administered Aprepitant and Placebo Prior to ERCP and One Day After ERCP:Assess the Total Number of Incidents of Post-ERCP Pancreatitis in Each Group (Treatment and Control). — 7; 7 cases of ERCP in participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: aprepitant (Drug); Placebo (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Duke University
Primary completion: Aug 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Post-ERCP Pancreatitis Cases in Participants Who Are Administered Aprepitant and Placebo Prior to ERCP and One Day After ERCP:Assess the Total Number of Incidents of Post-ERCP Pancreatitis in Each Group (Treatment and Control).	7; 7	—
SECONDARY Incidence of Pain Post-ERCP, Within 48 Hours of ERCP, and at 1 Week Post-ERCP; Unrelated to Pancreatitis	—	—
SECONDARY Number of Participants Who Were Hospitalized Within 7 Days Post-ERCP for Abdominal Pain That Did Not Meet Criteria for Acute Pancreatitis	6; 9	—

Summary

The purpose of this study is to determine if giving Aprepitant 4 hours before and for two days after ERCP decreases the risk of developing pancreatitis after ERCP.

Eligibility Criteria

Inclusion Criteria: Patients selected for the study will be those undergoing ERCP who are at high risk for development of post-ERCP pancreatitis

patients expected to undergo a sphincterotomy
patients with suspected sphincter of oddi dysfunction
patients with a known history in the past of post-ERCP pancreatitis
patients less than 60 years of age

Exclusion Criteria

active pancreatitis
if they are pregnant
known adverse reaction to aprepitant

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00736073). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.